Objectives: This study aimed to develop a conceptual model (CM) of the adult and pediatric experience of focal segmental glomerulosclerosis (FSGS), including disease signs/symptoms, treatment side-effects, and impact on functioning and wellbeing.

Methods: A review was conducted to identify relevant qualitative literature via an electronic database search (MEDLINE, Embase, PsycINFO; run June 2021) of journal articles, hand-searching conference proceedings, patient advocacy group websites and gray literature. Identified data (patient/caregiver quotes, author summaries/interpretations of patient experiences) were analysed using inductive, semantic thematic analysis techniques, aided by ATLAS.tiv7. Codes were applied to data and concepts (symptoms/impacts) were identified, named, and refined. A CM was developed by grouping related concepts into domains.

Results: In total, 13 sources were identified for analysis: 6 journal articles; 4 blogs; 2 videos; 1 unpublished interview study report. The CM indicates whether concepts were reported as applicable to adults and/or pediatric patients, whether concepts were reported to be disease signs/symptoms and/or side-effects and which domains were salient/most bothersome. Salient sign/symptom/side-effect domains included swelling/puffiness (edema), pain/aches/discomfort, fatigue, weight changes, skin problems, respiratory problems, and sleep problems. Some relationships between domains were interpreted: edema contributes to weight changes and skin problems; edema and skin problems (particularly skin stretching/breakage caused by swelling) may cause pain. Salient impact domains included emotional/psychological wellbeing, physical functioning/activities of daily living, social functioning, and work/school.

Conclusion: Secondary analysis of published qualitative literature permitted development of a CM describing the adult and pediatric experience of FSGS. As the CM is limited by the depth of data in the literature, qualitative interviews are recommended to refine the CM, confirm the salient/most bothersome concepts and confirm the extent of impact on daily life. The refined CM will provide a useful tool to inform the selection, development, and/or amendment of clinical outcome assessments for use in future FSGS clinical trials.